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Protocol Details

Evaluation of Patients with Liver Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

91-DK-0214

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: 100 Years

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Hepatitis B;
Hepatitis C;
Hepatitis D;
Chronic Hepatitis;
Natural History

Recruitment Keyword(s)

Liver Disease

Condition(s)

Hepatitis D;
Hepatitis C;
Hepatitis B;
Liver Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver.

Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up.

Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations.

Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.

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Eligibility

INCLUSION CRITERIA:

Affected Subjects

In order to be eligible to participate in this study, an affected participant must meet all of the following criteria:

1. >=2 years of age.

2. Meets one of the following:

a. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR

b. At risk for acute or chronic liver disease

Healthy Volunteers

In order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:

1. >= 18 years of age.

2. In good general health as evidenced by medical history

EXCLUSION CRITERIA:

Affected Participants

An affected participant who meets any of the following criteria will be excluded from participation in this study:

1. History of significant medical illnesses that might interfere with prolonged follow up evaluation

Healthy Volunteers

A healthy volunteer who meets any of the following criteria will be excluded from participation in this study:

1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases

2. Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)

3. Average alcohol consumption > 1 drink/day in past 6 months, per self-report

4. History of liver disease (with the exception of neonatal jaundice)

5. History of severe illness, infection or major surgery in the past year

6. History of cancer (with the exception of basal cell carcinoma resected > 1 year prior to enrollment)

7. BMI < 18 or BMI >25

8. Hemoglobin < 11 (women) or hemoglobin < 12 (men)

9. ALT >35 (men) or ALT >25 (women)

10. Alkaline Phosphatase >= 150

11. Bilirubin >2 g/dL

12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive

13. Pregnancy

14. Inability to provide informed consent


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

T. Jake Liang, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9B16
10 CENTER DR
BETHESDA MD 20814
(301) 496-1721
jakel@mail.nih.gov

Patricia E. Alcivar
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 4-5722
10 CENTER DR
BETHESDA MD 20814
(301) 435-6121
patricia.alcivar@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001971

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